Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. One critical aspect that often gets overlooked until it is too late is market access planning, which includes (but is not limited to) considerations related to coding, coverage, and reimbursement. Defining a market access strategy early in the development process, even in some cases as early as product conception prior to initial R&D, can significantly impact the success and adoption of a medical product, often as much if not more than any technical or regulatory challenge. In this blog post, we will explore the value of market access analysis and its role in the development of medical products.
What is a Market Access & Reimbursement Strategy for Medicinal Products?
Market access and reimbursement strategy is planning to ensure that the right patients get the right treatment and benefit from rapid, consistent, and sustained access to new medical products and therapies at the right price by having a solid strategy for obtaining positive coverage from third-party payers.
Why is it important to have a Market Access and Reimbursement Strategy?
Effective market access strategies can ensure sponsors receive the best reimbursement possible for their product, and ensure patients will have access to new medical products and therapies as soon as possible by establishing favorable relationships with both private and public payers and providing the data needed to demonstrate medical necessity. Proper planning ensures adequate compensation and encourages further growth and development, while allowing patients to have access to new and effective therapies as soon as possible and at a reasonable cost.
Best Time to Develop a Market Access and Reimbursement Strategy
Considering market access strategy early in the product development lifecycle and prior to regulatory approval could save time and money of planning and conducting clinical trials post-approval. Market access and reimbursement strategy planning conducted in parallel with regulatory planning can also ensure that a product successfully meets regulatory requirements and payer approval within a streamlined timeline.
Whether the product is "breakthrough" or me-too, may determine whether additional clinical or economic evidence will be needed to support adoption for payers. If additional evidence will be needed, it is important to plan for the additional resources that will be needed, and to ensure a smooth transition from pre-market studies that support regulatory approval, and the post-market studies that demonstrate clinical utility.
In many ways it’s never too early to consider these factors. In the diagnostic and medical device space, it’s often critical to consider market access and reimbursement strategies while in the product design phase. For therapeutics, it should at least be during Phase II of clinical development.
Key Considerations for Developing Your Market Access Strategy
There are many areas of focus when developing your market access and reimbursement strategy. It is important to evaluate these considerations early in your development process.
- Market Access: By considering the reimbursement environment, developers can proactively address potential barriers and challenges that may hinder adoption of their products. Careful market analysis helps identify reimbursement or evidence gaps, coverage limitations, and navigate existing federal or state legislative policy allowing developers to navigate and align regulatory and reimbursement requirements and develop strategies to facilitate product adoption and market penetration.
- Evidence Generation: Market access analysis provides insights into the evidence requirements necessary to secure coverage and sufficient reimbursement rates for a medical product. It helps identify analytical, clinical, and health economic evidence needed to demonstrate the product's effectiveness and value in a real-world setting. By considering reimbursement criteria early on, developers can align their clinical trial design, data collection, and economic modeling to generate the evidence required for successful reimbursement decisions by payers to better enable market adoption.
- Coding & Pricing Strategy: Market access analysis guides developers in formulating an effective pricing strategy. By understanding the existing reimbursement landscape, including the use of billing codes recognized by payers in the competitive market at different sites of care where the product is used, developers can optimize pricing decisions and ensure affordability and access for patients. It helps strike a balance between pricing competitively and generating sufficient revenue to sustain innovation and further product development.
- Investor and Stakeholder Confidence: Lastly, thoughtful market analysis enhances investor and stakeholder confidence in future commercial success. By demonstrating a clear understanding of the reimbursement landscape and addressing potential barriers or showing potential opportunities, developers can present a compelling case for investment. Robust reimbursement analysis instills confidence in investors, regulatory agencies, and healthcare providers, fostering collaborations and support for the product's development and market introduction.
Market access planning is a critical component in the development of medical products. By evaluating market viability, guiding evidence generation, shaping pricing strategies, facilitating positive coverage and reimbursement decisions, and instilling stakeholder confidence, reimbursement analysis sets the stage for successful commercialization and patient impact. Incorporating reimbursement considerations early in the development process can help optimize the chances of achieving widespread adoption, improving patient care, and driving innovation in healthcare.
Consequences of Poor Market Access and Reimbursement Strategy
Failure to plan and execute a high-quality market access and reimbursement strategy can result in a cascade of non-coverage decisions by payers leading to poor market acceptance by clinicians or patients who ultimately cannot access technologies without that coverage. Ultimately non-coverage could cost developers millions of dollars and delay the product launch of much needed patient medical products and therapies.
Should You Work with Consultants to Develop Your Market Access and Reimbursement Strategy?
Working with consultants to develop market access and reimbursement strategy offers significant value to developers by providing industry, regulatory, and policy knowledge about the application of advanced approaches allowing for the development of a strategic roadmap that aligns actions to achieve regulatory approval, coverage of a new technology, and the engagement of relevant stakeholders to support the plan.
Talk to Market Access and Reimbursement Strategy Experts
ProPharma is your trusted partner in navigating the intricacies of market access and reimbursement strategies. Our team of experts have decades of experience developing tailored strategies that help companies overcome barriers, optimize pricing decisions, and foster investor confidence. Let us guide you towards successful commercialization and meaningful patient impact.
Contact us now to unlock the full potential of your medical products in the dynamic healthcare landscape. We are here to help you take the first step towards a successful market entry.
